- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07572149
THE EFFECT OF FOOD SAFETY TRAINING ON EMPLOYEES' KNOWLEDGE, ATTITUDES, AND PRACTICES: A SOLOMON FOUR-GROUP EXPERIMENT (SOLOMON-KAP)
THE EFFECT OF FOOD SAFETY TRAINING ON KNOWLEDGE, ATTITUDE AND PRACTICES (KAP) OF FOOD INDUSTRY EMPLOYEES: AN EVALUATION USING THE SOLOMON FOUR-GROUP EXPERIMENTAL DESIGN
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Methods Study Design and Setting This study was designed as a randomized controlled trial employing a Solomon four-group experimental design to evaluate the effectiveness of a food safety training program. The study was conducted among food industry employees working in municipal social facilities. The Solomon four-group design was selected to assess the true effect of the intervention while controlling for potential pretest sensitization bias, thereby strengthening both internal and external validity.
Participants and Sample Size A total of 278 food industry employees working in municipal facilities were assessed for eligibility. Sample size calculation was performed using the Epi Info software based on an assumed food safety training prevalence of 85.9%, derived from previous studies, with a 5% margin of error and a 95% confidence interval. The minimum required sample size was calculated as 186 participants. To account for potential data loss, this number was increased by 10%, resulting in a final target sample size of 200 participants.
Eligible participants were adults aged 18 years or older, employed in the food sector, and possessing at least basic literacy skills. Individuals who declined participation or had communication barriers were excluded from the study.
Reasons for exclusion and participant flow throughout the study are presented in Figure 1.
Randomization and Group Allocation Following eligibility assessment and informed consent, 200 participants were randomly allocated into four groups using a random numbers table, with 50 participants assigned to each group. The randomization process, group allocation, intervention exposure, follow-up, and final analysis numbers are summarized in Figure 1.
- Intervention Group 1 (Pretest + Training + Posttest)
- Intervention Group 2 (Training + Posttest)
- Control Group 1 (Pretest + Posttest)
- Control Group 2 (Posttest only) The flow of participants through the study and group allocation process is illustrated in Figure 1.
Intervention Development of Training Content Baseline data obtained from Intervention Group 1 and Control Group 1 (the pretested groups) were analyzed to identify gaps in food safety knowledge, attitudes, and practices. These baseline findings were used to inform and tailor the content of the food safety training program, ensuring that the intervention addressed participants' identified needs.
Based on this needs assessment, a structured training program consisting of three modules was developed:
- Personal hygiene knowledge, attitudes, and practices
- Workplace hygiene knowledge, attitudes, and practices
- Safe food preparation processes Delivery of the Training Program The training intervention was delivered face-to-face by the research team in designated training halls within municipal facilities. The program consisted of three sessions, each comprising a 35-minute structured lecture followed by a 10-minute question-and-answer and discussion period. A 15-minute break was provided between sessions, and a maximum of 25 participants attended each session.
Participants in the intervention groups received the training program, whereas no intervention was applied to the control groups during the study period. To ensure ethical standards, control group participants were offered the same training after completion of posttest data collection.
Data Collection Instruments Data were collected using a structured questionnaire developed by the researchers based on relevant literature and expert consultation. The questionnaire comprised five sections with a total of 64 items assessing sociodemographic characteristics, previous food safety training, food safety knowledge, attitudes and practices. A pilot test was conducted with 10 food industry employees prior to data collection, and necessary revisions were made to improve clarity and relevance. The timing of pretest and posttest assessments, as well as the two-month follow-up period, are illustrated in Figure 1.
Details of the questionnaire items and scoring procedures are provided in the Supplementary Material.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
-
-
-
Kayseri, Tyrkiet (Türkiye)
- Kayseri Metropolitan Municipality
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Beskrivelse
Inclusion Criteria:
- Being 18 years of age or older
- Working in the food sector
- Having at least basic literacy skills
Exclusion Criteria:
- Refusing to participate in the study
- Having communication difficulties
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Sundhedstjenesteforskning
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Andet: CONTROL GROUP 1
Pretest assessment
|
The reminder effect of the pretest will be evaluated.
|
|
Andet: CONTROL GROUP 2
|
The reminder effect of the pretest will be evaluated.
|
|
Eksperimentel: INTERVENTION 1
Food safety training program
|
The reminder effect of the pretest will be evaluated.
The interventions consisted of a structured face-to-face food safety training program covering personal hygiene, workplace hygiene, and safe food preparation practices.
|
|
Eksperimentel: INTERVENTION 2
Food safety training program
|
The interventions consisted of a structured face-to-face food safety training program covering personal hygiene, workplace hygiene, and safe food preparation practices.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Score change
Tidsramme: In the control group, the post-test was administered 8 weeks after the pre-test, while in the intervention group, the post-test was administered 8 weeks after the training was provided.
|
No standardized scale was used in the study. The questions in the questionnaire were developed based on expert opinions. There is no cut-off point or defined score range for the scores obtained from the questions. The questionnaire used in the study was developed by the researchers based on a literature review and consisted of five sections and 64 questions. The first section of the questionnaire (questions 1-10) included the socio-demographic characteristics of the employees; the second section (questions 11-15) included their status of receiving training on food safety; the third section (questions 16-35) assessed their knowledge about food safety; the fourth section (questions 36-45) assessed their attitudes toward food safety; and the fifth section (questions 46-64) assessed their food safety practices. For the statements in the third section, participants selected the option that best suited them from "True," "False," or "I don't know." Participants received 1 point for each que |
In the control group, the post-test was administered 8 weeks after the pre-test, while in the intervention group, the post-test was administered 8 weeks after the training was provided.
|
Samarbejdspartnere og efterforskere
Sponsor
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 2021/799
- SOLOMON-KAP STUDY (Anden identifikator: SOLOMON-KAP STUDY)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
IPD-planbeskrivelse
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
Kliniske forsøg med Sundhedsuddannelse
-
Foundation University IslamabadAfsluttetGamification in Health EducationPakistan
-
Antalya Bilim UniversityAktiv, ikke rekrutterendeAkademisk præstation | Uddannelsesforstærkning | Jordemoderuddannelse | Studerendes motivation | Gamification in Health EducationKalkun
-
Suleyman Demirel UniversityAfsluttetGamification | Sygeplejestuderende | Akademisk præstation | Spilbaseret læring | Gamification in Health Education | Spilbaseret læring | Gimkit | Respiratoriske System Færdigheder | PræstationsmotivationTyrkiet (Türkiye)
-
Sakarya UniversityRekrutteringPostpartum blødning | Gamification | Sygeplejestuderende | Sygepleje | Gamification in Health Education | SygeplejerskeuddannelseTyrkiet (Türkiye)
-
Namik Kemal UniversityTilmelding efter invitationUddannelse | Sygeplejestuderende | Flipped Education ModelTyrkiet (Türkiye)
-
Istanbul University - CerrahpasaAfsluttetEvidensbaseret praksis | Flipped Education ModelKalkun
-
Universidad de ExtremaduraDiputación Provincial de BadajozRekrutteringSundhedsuddannelse | Gamification in Health EducationSpanien
-
The Hospital for Sick ChildrenAfsluttetEvaluering af HomeCare RN Respiratory EducationCanada
-
Istanbul University - CerrahpasaAktiv, ikke rekrutterendeMetakognition | Flipped Education Model | Web Baseret Uddannelse | Selvstyret læringKalkun
-
Eastern Mediterranean UniversityAfsluttetSygeplejestuderende | Flipped Education ModelCypern
Kliniske forsøg med Pretest assessment
-
PREtest ConsultUkendtAkut koronarsyndromForenede Stater
-
Al-Azhar UniversityRekrutteringCaries i tænderne | Udbrud | BMIEgypten
-
Empatica, Inc.United States Department of DefenseAfsluttet
-
Thomas Jefferson UniversityAfsluttetHæmatopoietisk og lymfoid celle-neoplasma | Ondartet fast neoplasmaForenede Stater
-
Guy's and St Thomas' NHS Foundation TrustMacusoftIkke rekrutterer endnuDiabetisk makulært ødem | Retinal veneokklusion | Våd makuladegenerationDet Forenede Kongerige
-
University Hospital, LilleAfsluttetKognitivt symptom | Evalueringer, Diagnostisk SelvFrankrig
-
Texas Woman's UniversityAfsluttetAutismespektrumforstyrrelse
-
Alzheimer's Light LLCRekrutteringMultipel sclerose | Parkinsons sygdom | Alzheimers sygdom | Mild kognitiv svækkelse | Frontotemporal demens | Vaskulær demens | TBIForenede Stater
-
University of OklahomaTrukket tilbageLivmoderhalskræft | Hoved- og halskræft | Gynækologisk kræft | EndometriecancerForenede Stater
-
Natera, Inc.Trukket tilbageHjertetransplantationssvigt og afvisning